1. Field of the Invention
The present invention relates, e.g., to methods of preparing dried pharmaceutical compositions, in particulate (e.g., in powder) form. Such compositions are suitable for administration to, e.g., mucosal tissues (e.g., following intranasal administration). Compositions prepared by the methods of the invention, and methods of administering the compositions to a patient, are also described. Exemplary inventive compositions include insulin, and influenza (“flu”) vaccines comprising inactivated viral particles or a nucleic acid encoding influenza haemagglutinin.
2. Background Information
Methods have been reported for formulating dried pharmaceutical compositions. These methods include, e.g., steps of precipitation, spray-drying, and/or mechanical milling of dried substances. Some of the reported methods utilize non-aqueous solvents to provide rapid moisture evaporation and to reduce processing time. Such solvents can damage the pharmaceutical agents (e.g., proteins) being dried. Particles produced by the reported methods often exhibit a tendency to agglomerate, and/or lack a suitable size, density (e.g., tap density), morphology and/or stability for optimal pharmaceutical use.
There is a need for methods to produce dried pharmaceutical compositions that lack one or more, or other, of the above-mentioned drawbacks.